This study looks at how well a combination of treatments helps reduce pain in people with tumors in the middle and lower back (thoracic and lumbar spine). All participants receive the same treatment, which includes a procedure to stabilize the spine (kyphoplasty), radiofrequency ablation will be with the Osteocool system and radiation therapy. The goal is to see how effective this combined approach is at relieving pain.
The purpose of this study is to find out whether combining these three treatments provides better pain relief for patients with thoracic and lumbar spine tumors. This study is for adults who have cancer that has spread to the thoracic or lumbar spine and who report moderate to severe back pain (a pain score of 5 or higher on a 0-10 pain scale).
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
Age ≥ 18 years at the time of consent.
Life expectancy beyond completion of protocol intervention of at least 1 month and deemed appropriate for treatment based on multidisciplinary review and/or investigator discretion.
Active infection requiring systemic therapy.
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Is currently taking Avastin or anti-coagulant meds that cannot be held.
Is currently enrolled in a cancer related clinical trial.
Patient with metastatic thoracic and lumbar spine tumors treated at UNC Chapel Hill
Cohort
Prospective
kyphoplasty with Osteocool
Procedure/SurgeryParticipants will receive kyphoplasty with Osteocool prior to their Standard of Care External Beam Radiotherapy.
Change in pain intensity
Change in pain intensity will be measured using visual analog scale (VAS) assessments, from baseline (pre-therapy) to 1 month post completion of radiotherapy.
Presence of thoracic and lumbar spine tumors
Presence of thoracic and lumbar spine residual tumors will be determined by independent radiology report (clinical assessment by a non-investigator) based on any standard of care imaging exam per treating physician's discretion.
Long term new or worsened vertebral body compression fracture
Long term new or worsened vertebral body compression fracture of thoracic and lumbar spine tumor subjects treated with kyphoplasty with osteocool ablation plus radiation therapy at the treated level will be determined by independent radiology report (clinical assessment by a non-investigator) based on any standard of care imaging exam per treating physician's discretion.
Retreatment of thoracic and lumbar spine tumor
Retreatment of thoracic and lumbar spine tumor subjects treated with kyphoplasty with Osteocool ablation plus radiation therapy is defined as treatment at the same vertebral body level with kypho- radiation therapy for disease progression within 6-months of protocol intervention collected via medical record abstraction as compared to historical control.
Quality of life per Patient-Reported Outcomes version of the Common Terminology Criteria
Quality of life in patients with thoracic and lumbar spine tumors treated with kyphoplasty with Osteocool ablation plus radiation therapy will be evaluated using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurements prior to therapy and at completion of therapy and 6 months after procedure. PRO-CTCAE is a questionnaire that lets patients report symptoms they experience during treatment, such as pain, fatigue, nausea, or skin changes. It measures how often symptoms occur, how severe they are, and how much they interfere with daily activities. Each symptom is scored from 0 to 4 (or 0/1 for absent or present). There is currently no standard method for combining scores into a single overall score.
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UNC Lineberger Comprehensive Cancer Center
Lead sponsor
Medtronic
Collaborator
